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510(k) K231461

Smart Correction System (HA Half Pins) by Wishbone Medical, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
May 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Wishbone Medical, Inc.

  • K230527 — WishBone Medical Plate and Screw System (March 29, 2023)
  • K221366 — Smart Correction System Rings and Compatible HA-Coated Half Pins (June 6, 2022)
  • K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula (January 27, 2022)
  • K203467 — WishBone Medical Plate and Screw System (December 23, 2020)
  • K193368 — Smart Correction System (September 18, 2020)
  • K182704 — WishBone Guided Growth System (June 25, 2019)
  • K180736 — WishBone Medical Plate and Screw System (October 4, 2018)
  • K173013 — WishBone K-Wire System (December 14, 2017)

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  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)